Real-world effect of traditional Chinese medicine combined with secukinumab in patients with psoriasis:protocol of a multi-center cohort study
- Conditions
- psoriasisL40.951
- Registration Number
- ITMCTR2200005870
- Lead Sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Age = 18 years old.
(2) Patients with moderate to severe chronic plaque psoriasis for at least 6 months.
(3) Patients were inadequately controlled by topical treatments, phototherapy, and/or previous systemic therapy.
(4) The disease was moderate to severe, psoriasis area severity index [PASI] =12, Investigators Global Assessment [IGA] score =3, and body surface area [BSA]involvement =10%.
(5) The diagnostic criteria of TCM syndromes accord with psoriasis blood heat syndrome, blood dryness syndrome or blood stasis syndrome.
(6) Signed the informed consent form, and the sign process complied with the provisions of GCP.
Those who meet all of the above six conditions at the same time are selected.
(1) criteria included forms of psoriasis other than chronic plaque-type psoriasis, drug-induced psoriasis.
(2) Previous use of biological agents (including TNFaInhibitor, IL12/23 inhibitor or IL-17A inhibitor, etc.).
(3) Patients who are participating in clinical trials of other drugs.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 90% and above PASI score resolution rate;patients with IGA 0 (clear) or 1 (almost clear);
- Secondary Outcome Measures
Name Time Method 75% reduction in PASI score;body surface area;Disease Recurrence Rate During Follow-up;psoriasis area and severity index;Dermatology Life Quality Index;